Model Number N/A |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the rivet popped out of the clamp.Another device was used to complete the surgery.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device confirms that the rivet is missing from the device.The device exhibits wear (scratches, nicks) indicating signs of usage.Failure mode: market use : functional : components disassembled the likely condition of the part when it left zimmer biomet control: conforming device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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